During the course of the conduct of a study it may be necessary to make changes to the study. These might be due to new personnel, unexpectedly high screen failure rates, changes to minimize risks, addition of new recruitment materials, as well as a whole host of other reasons. Changes to an IRB approved study must receive IRB approval prior to implementation unless the change is made to eliminate an apparent immediate hazard to a subject. This KBA walks users through how to submit an amendment in Kuali IRB.
Steps to Take
1. Start by logging in to Kuali IRB.
2. Find the study you wish to submit an amendment for and enter the study record by clicking on the blue study title (see green box in screenshot below).
- NOTE: Be sure you're entering the currently approved version of the study by checking the "Status" column for the words "Approved," "Exempt," or "External Reliance" (see red box in screenshot below).
- NOTE: For studies which rely on a non-UCSD IRB (noted by a status of "External Reliance") OIA does not need to review and accept all amendments submitted to the reviewing IRB. For a list of required amendments, please see our sIRB page on Reliance Requests. If a submission is made for a study which relies on a non-UCSD IRB solely to alert OCAA of the change, please select "yes" to the first question in the amendment application (see screenshot just below step 6) to submit a truncated amendment application.
3. Once in the study, click "Amend" from the right-hand menu (see purple box in the screenshot below).
4. A pop-up box will open in the screen. Select the check boxes for the sections of the Kuali application for which you wish to make changes (e.g. if changing study personnel click the box for "Project Basics/Study Personnel" or if changing, adding, or removing documents click the box for "Supporting Information"). These are indicated in the orange box in the screenshot below. Then click "Done" at the bottom of the pop-up box (see blue box in screenshot below).
5. The system will automatically generate an amendment application.
6. At the top of the amendment application will be a number of questions to be answered (see red box in screenshot below), based on whether the study is being reviewed by an external IRB or not, that help the IRB understand what the changes are and why they're being requested. You'll also see the sections on the left-hand side of the screen which are available for editing denoted by a green circle with a lightning bolt symbol (see green box in screenshot below).
7. Complete the questions at the top of the amendment application and then proceed through the Kuali application making the relevant changes.
8. If you are changing, adding, or deleting documents as a part of the amendment, follow these instructions:
- For documents that are changing, keep in mind the IRB still requires a clean and tracked changes copy be submitted so we can review the specific changes that are made. To submit a new version of an already existing document, click the "Replace" button just under the document's file name in the left-most column (see orange box in the screenshot below). This will open a dialogue box where you can select the new document that should replace the previously approved document. Update the far-right column of the table in the "Supporting Information" section as necessary.
- NOTE: For documents which will be stamped (i.e. consent documents, assent documents, and recruitment materials), the clean version of the document must be submitted in PDF format and cannot contain prior IRB stamps. If the document contains prior IRB stamps or is submitted in a format other than PDF, Kuali will not be able to apply the stamp to the document.
- For completely new documents, add them to the "Supporting Information" section by clicking the "+ Add Line" button in the upper-right corner of the "Supporting Information" section within the Kuali application (see blue box in screenshot below). Then scroll down to the bottom of the table and either drag and drop the file for the new document or click the "+ Choose" button to find the new document in your files. Once the document is uploaded, complete the other two columns in the table for the document.
- For documents that are no longer being used for the study and are not being replaced by an updated version, these can be deleted from Kuali by clicking the trashcan icon to the left of the document file name (see purple box in the screenshot below).
- NOTE: Documents should only be deleted if they will no longer be used for the study (e.g. the study is now closed to enrollment so recruitment materials can be deleted). If a document will still be used but is not a part of the amendment, it should not be deleted (e.g. there is a protocol update which doesn't change the consent document but the study is still open to enrollment of new subjects, the consent document should not be deleted).
9. Sometimes when making changes to parts of the Kuali application a team member may realize that they didn't "unlock" all the sections they need to change or new sections of the Kuali application have appeared that need to be completed (e.g. adding children as a subject population that will be specifically recruited). If this happens, click "Add/Remove Section" from the right-hand menu in Kuali (see red box in screenshot below). Complete the actions in Step 4 above to add the additional sections that need to be revised/completed to the amendment.
10. Once the amendment application questions have been answered and all changes have been made. Click "Submit" from the right-hand menu to submit the amendment to OIA for review (see green box in screenshot below).